DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 19 Dec 2025. As directed by the amendment: claims 1, 6-9, and 11 have been amended, claims 5 and 15-20 have been canceled, and no claims have been added. Thus, claims 1-4 and 6-14 are presently pending in this application.
Response to Arguments
35 USC § 101 Rejections
Applicant’s arguments, see Remarks, filed 19 Dec 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered and are persuasive in light of the claim amendments. The rejections under 35 U.S.C. 101 have been withdrawn.
Rejections Over the Prior Art
Applicant’s arguments, see Remarks, filed 19 Dec 2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kibler et al. (US 20200316391 A1), hereinafter Kibler.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kibler et al. (US 20200316391 A1), hereinafter Kibler.
Regarding claim 1, Kibler discloses a method for determining one or more first thresholds for therapeutic stimulation provided to a patient (Fig. 2, paragraph [0076]) by an implantable neurostimulator (Fig. 1, paragraph [0062], implantable medical device 1), comprising:
(a) providing test stimulation to the patient via the implantable neurostimulator (Fig. 2, paragraph [0063], step S1, "an eCAP threshold search by stimulating the neural tissue by means of the electrodes 12 with test stimulation pulses"), wherein the test stimulation is provided at a plurality of different test pulse widths (paragraph [0023], "eCAP threshold search may comprise delivering stimulation with consecutive test stimulation pulses having an increasing pulse width until an eCAP is detected for at least two consecutive widths");
(b) determining a value for a neural response at each of the test pulse widths, wherein the neural responses are formed in response to the test stimulation and comprise Evoked Compound Action Potentials (Fig. 2, paragraph [0076], step S2, "each of an eCAP threshold amplitude and a coupling factor are determined based on the eCAP threshold search"; paragraph [0063], "the stimulation amplitude may be ramped up until eCAPs are sensed");
(c) determining a first mathematical relationship that models values for the neural responses as a function of pulse width using the values for the neural responses as determined at each of the test pulse widths (paragraph [0064], "The coupling factor would be calculated by determining the activation threshold of the target neuronal fiber group as mapped in a strength-duration curve");
(d) providing the therapeutic stimulation to a spinal cord of the patient via the implantable neurostimulator to treat the patient's back pain (paragraphs [0062], [0095]), wherein the therapeutic stimulation comprises a plurality of stimulation parameters including a therapeutic pulse width (paragraph [0064], "a target therapy applying a pulse width p2");
(e) determining a value of a neural response to the therapeutic stimulation using the first mathematical relationship (paragraph [0064], "For a target therapy applying a pulse width p2 and frequency f1, the fiber activation threshold could be calculated from the coupling factor by finding the activation threshold of the target neuronal fiber group as mapped in a strength-duration curve similar to that shown in FIG. 4 at x=p2, and dividing this threshold by the coupling factor"); and
(f) determining one or more first thresholds for the therapeutic stimulation using the determined value of the neural response to the therapeutic stimulation, wherein each first threshold is determined using a second mathematical relationship that models each first threshold as a function of values of the neural response to the therapeutic stimulation (paragraph [0091], "For sub-perception stimulation, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value less than 1, typically in the range of 0.1-0.6. For paresthesia-based therapy, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value of typically 1.0-1.15.").
Regarding claim 2, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that the one or more first thresholds comprise thresholds for one of the stimulation parameters that causes a physiological response in the patient, wherein the physiological response comprises one or more of paresthesia and discomfort (paragraph [0091], "For paresthesia-based therapy, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value of typically 1.0-1.15.").
Regarding claim 3, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that the one or more first thresholds comprise physiological thresholds, wherein the one or more physiological thresholds comprise one or more of a perception threshold and a discomfort threshold (paragraph [0091], "For sub-perception stimulation, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value less than 1, typically in the range of 0.1-0.6.").
Regarding claim 4, Kibler discloses the method of claim 3, as explained above. Kibler further discloses that the one or more first thresholds comprise thresholds for an amplitude of the therapeutic stimulation (paragraph [0091], "For sub-perception stimulation, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value less than 1, typically in the range of 0.1-0.6. For paresthesia-based therapy, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value of typically 1.0-1.15.").
Regarding claim 6, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that the values for the neural responses at each of the test pulse widths comprises a value of a parameter of the test stimulation, wherein the value for the neural response comprises a minimum value of the test stimulation parameter at which the neural response is detectable (paragraph [0023], "eCAP threshold search may comprise delivering stimulation with consecutive test stimulation pulses having an increasing pulse width until an eCAP is detected for at least two consecutive widths").
Regarding claim 7, Kibler discloses the method of claim 6, as explained above. Kibler further discloses that the test stimulation parameter comprises an amplitude of the therapeutic stimulation (paragraph [0063], "the stimulation amplitude may be ramped up until eCAPs are sensed by means of the detection electrodes 14").
Regarding claim 8, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that the second mathematical relationship that models each first threshold is a linear function of the values of the neural response to the therapeutic stimulation (paragraph [0091], "For sub-perception stimulation, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value less than 1, typically in the range of 0.1-0.6. For paresthesia-based therapy, the therapy amplitude may be calculated by multiplying the translated coupling factor by a value of typically 1.0-1.15.").
Regarding claim 9, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that the values for the neural responses at each of the test pulse widths comprise extracted neural thresholds (paragraph [0063], "the stimulation amplitude may be ramped up until eCAPs are sensed by means of the detection electrodes 14").
Regarding claim 10, Kibler discloses the method of claim 1, as explained above. Kibler further discloses that an external device communicates with the implantable neurostimulator (Fig. 1, paragraphs [0069], [0085], programmer device 2).
Regarding claim 11, Kibler discloses the method of claim 10, as explained above. Kibler further discloses that the value for the neural responses at each of the test pulse widths is determined in the external device (paragraph [0071], "the programmer device 2 may be configured for determining, based on the results of the eCAP search, the eCAP threshold amplitude and the coupling factor").
Regarding claim 12, Kibler discloses the method of claim 10, as explained above. Kibler further discloses that the method is initiated at a user interface of the external device (paragraph [0073]).
Regarding claim 13, Kibler discloses the method of claim 10, as explained above. Kibler further discloses that the second mathematical relationship for each of the first thresholds is stored in the external device (paragraphs [0068], [0083]).
Regarding claim 14, Kibler discloses the method of claim 13, as explained above. Kibler further discloses that the one or more first thresholds is determined in the external device (paragraphs [0074], [0082], [0084], [0092]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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